Senior Director, Head of Clinical Monitoring and Operational Systems

MapLight Therapeutics, Inc.

. Ensure global clinical monitoring is executed with high standards of quality and consistency .

Posted 5/2/2026full-timeRemote • Massachusetts • 🇺🇸 United StatesSenior💰 $270,000 - $300,000 per yearWebsite

Tech Stack

Tools & technologies

Google Cloud Platform

About the role

Key responsibilities & impact

Ensure global clinical monitoring is executed with high standards of quality and consistency
Oversee Lead CRAs and provide support and guidance for their management of monitoring teams
Enhance the framework for clinical site monitoring and site management strategies
Oversee the Clinical Operations Systems team to support the continued development, efficiency and integrity of the eTMF and CTMS systems
Accountable to strengthen the monitoring, site management and clinical systems quality oversight strategy
Develop standardized key performance indicators (KPIs) and key quality indicators (KQIs)
Grow and develop team members in the clinical monitoring and operations systems team
Represents the monitoring and clinical operations system functions in senior management meetings

Requirements

What you’ll need

Bachelor’s degree in a relevant field
a minimum of 12 years in the clinical trial industry with at least 5 years experience onsite clinical monitoring
A minimum of 5 years providing global trial monitoring oversight with direct management of monitors
Experience managing FSP/CRO monitoring teams and developing monitoring quality metrics, KPIs
Demonstrated experience with a variety of CTMS and eTMF platforms
Demonstrated ability to be versatile and serve as a role model
Competency in technical systems that improve efficiencies (ex. Power BI)
Demonstrates core understanding of medical terminology and clinical trial activities
Deep working knowledge of ICH-GCP, FDA, EMA, and other global regulatory requirements
Demonstrated ability to attend to detail and make effective presentations
Ability to travel independently by air, car and/or train

Benefits

Comp & perks

annual bonus opportunity
medical, dental, vision, life and AD&D insurance
short term and long term disability
401(K) plan with match
stock options
flexible non-accrual paid time off
parental leave

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills & Tools

clinical monitoringclinical trial managementmonitoring quality metricskey performance indicatorskey quality indicatorsmedical terminologyregulatory complianceICH-GCPFDA regulationsEMA regulations

Soft Skills

leadershipteam developmentattention to detailpresentation skillsversatilityguidancesupportcommunicationmanagementstrategic oversight